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Standard in Focus: DIN EN ISO 80601-2-70:2021-06 Medical Electrical Equipment

Medical electrical equipment

Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

Obstructive Sleep Apnea

The standard for medical electrical equipment applies to sleep apnea respiratory therapy devices. Obstructive sleep apnea (OSA) is a fairly common and serious sleep-related breathing disorder. During sleep, there is repeated reduction or complete cessation of breathing. This is caused by a temporary constriction of the throat lasting up to minutes. The closure of the airways leads to a drop in the oxygen concentration in the blood and a reduced supply of oxygen to the organs and, among other things, to repeated waking up during an overall non-restful night. The medical devices discussed here alleviate the symptoms of OSA and are operated and used by laypersons in the home care setting as well as professionals in healthcare facilities.

This completely revised standard medical electrical equipment from 2021-06 replaces DIN EN ISO 17510-1:2009-07, which was withdrawn in June of this year.

Amendments include:

  • an adaptation to DIN EN 60601-1:2007-07 and to
  • an adaptation to supplementary standards of the 60601 series of standards
  • a revision of the performance requirements for sleep apnea respiratory therapy devices
  • addition of test procedures
  • Addition of requirements for functional connections to support a remote connection
  • Addition of an informative annex on a data interface
  • Revisions to labeling and manufacturer information requirements (see our articles from May and June of this year for more information)

In order to meet the requirements, fundamental device revisions will be necessary in some cases. In addition to the accompanying information and definitions, essential safety devices and device connections are affected by the changes.

If you are a manufacturer of sleep apnea devices, make sure to contact your testing laboratory or talk to our experts. In the GKV Spitzenverband list of medical technical aids, systems for the treatment of sleep-related breathing disorders are listed under aid numbers 14.24.20.Xxxx.

Contact us! We will be happy to explain the effects of the new standard on your listing and help you when it comes to new listings and maintaining your listing.

 

 

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